Early Manifest Glaucoma Trial (EMGT)
Information source: National Eye Institute (NEI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-Angle Glaucoma
Intervention: Betaxolol (Drug); Argon Laser Trabeculoplasty (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Eye Institute (NEI)
Summary
The primary purpose is to compare the effect of immediate therapy to lower the intraocular
pressure (IOP) versus late or no treatment on the progression of newly detected open-angle
glaucoma, as measured by increasing visual field loss and/or optic disc changes.
The secondary purposes are to determine the extent of IOP reduction attained by treatment,
to explore factors that may influence glaucoma progression, and to describe the natural
history of newly detected glaucoma.
Clinical Details
Study design: Allocation: Randomized, Primary Purpose: Treatment
Detailed description:
Glaucoma is a common disease in older adults. All present treatment aims at reduction of
the intraocular pressure, but indications for therapy are not well defined. Furthermore, it
is unclear whether intraocular pressure influences the natural history of glaucoma. Against
this background, the primary aim of the study is of central importance to patients with
manifest and suspect glaucoma.
Glaucoma has few subjective symptoms during a long period early in the disease, but damage
is irreversible once it occurs. Early diagnosis and rapid detection of progression are of
paramount importance in limiting this damage, whether through pressure reduction or in some
other way. The effectiveness, if any, of lowering the intraocular pressure in glaucoma
requires evaluation by controlled treatment trials.
The Early Manifest Glaucoma Trial (EMGT) is the first large, controlled, randomized clinical
trial to evaluate the effect of lowering the intraocular pressure on the progression of
newly detected, open-angle glaucoma. This study will compare glaucoma progression in
initially treated versus untreated patients with newly detected open-angle glaucoma and will
allow quantification of the effect of immediate IOP-lowering treatment on progression during
the followup period.
The EMGT is a collaborative effort that involves a Clinical Center at the Department of
Ophthalmology of Malmo University Hospital at the University of Lund, Sweden, and its
Satellite Center in Helsingborg, Sweden; an independent Data Center at the Department of
Preventive Medicine, University Medical Center at Stony Brook, New York; and a Disc
Photography Reading Center at the Department of Ophthalmology in Lund at the University of
Lund. The study was initiated with support from the Swedish Medical Research Council.
Recruitment for the study has been completed. The 255 patients were identified by an
extensive, population-based screening of successive age cohorts as well as by clinical
referral. The diagnosis was confirmed through Humphrey perimetry at two postscreening
visits to the Clinical Center or Satellite Center. Eligible patients who agreed to
participate had two additional visits for collection of baseline data. They were randomized
to treatment with the beta blocker Betaxolol and argon laser trabeculoplasty (treated group)
or to no initial treatment (control group) with close followup of both groups.
Patients are followed for a minimum of 4 years to assess the development of glaucoma
progression. They are seen every 3 months to collect visual field, IOP, and other data.
Disc photographs are taken every 6 months. Technicians and disc photograph graders are
masked regarding treatment assignment. Additional followup visits are held to confirm
visual field progression and IOP elevation (>25 mm Hg in treated group, >35 mm Hg in control
group). Patients in the treated group receive Xalantan whenever IOP exceeds 25 mm Hg at
more than one visit; patients in the control group will receive Xalantan whenever IOP
reaches 35 mm Hg or higher during the trial. If IOP remains high, individualized treatment
is given. All patients continue to be followed to monitor the development of end points and
will be analyzed in their originally assigned groups.
The study outcome is glaucoma progression, which is based on specific criteria derived from
analyses of Humphrey visual fields and masked evaluations of disc photographs. The
perimetric outcome is defined as statistically significant deterioration (p < 0. 05) of the
same three or more test points in Pattern Deviation Change Probability Maps in three
consecutive C30-2 Humphrey fields. Optic disc progression is determined by the following:
- The presence of definite change (detected by comparison of followup photographs with
baseline) by flicker chronoscopy in two followup photographs from the same visit, with
independent confirmation by side-by-side gradings.
- Final confirmation of change toward progression, by flicker chronoscopy and by
side-by-side gradings, at a different followup visit.
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Men and women between ages 50 and 80 years who have newly detected and untreated chronic
open-angle glaucoma with repeatable visual field defects by Humphrey perimetry are
eligible for inclusion.
Exclusion criteria include the following: advanced visual field loss (MD less than or
equal to 16 dB) or threat to fixation; mean IOP > 30 mm Hg or any IOP > 35 mm Hg in at
least one eye; VA < 0. 5 in either eye; or any conditions precluding reliable fields or
photos, use of study treatment, or 4-year followup.
Locations and Contacts
Department of Ophthalmology, Helsingborg Hospital, Helsingborg, Sweden
Department of Ophthalmology, Malmo University Hospital, University of Lund, Malmo, Sweden
Additional Information
Starting date: October 1992
Last updated: June 23, 2005
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